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A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

AbbVie · NCT05711394

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
450
US sites recruiting
26
Study start
May 1, 2023
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.

Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.

Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks.

There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Being studied: Atogepant; Placebo-Matching Atogepant

Conditions: Episodic Migraine

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Weight is >= 20 kg (44 lbs) and \< 135 kg (298 lbs).
  • History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
  • Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary.
  • To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 [2018]) and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion Criteria

  • History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
  • Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
  • Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Recruiting US locations

  • Rehabilitation & Neurological Services /ID# 248517

    Huntsville, AL 35805-4046

  • The Center for Clinical Trials - Saraland /ID# 271604

    Saraland, AL 36571

  • Preferred Research Partners /ID# 249729

    Little Rock, AR 72211

  • Advanced Research Center /ID# 251381

    Anaheim, CA 92805

  • Alliance for Research Alliance for Wellness /ID# 248521

    Long Beach, CA 90807

  • Lumos Clinical Research Center /ID# 249731

    San Jose, CA 95124-4108

  • Sunwise Clinical Research /ID# 248529

    Walnut Creek, CA 94596

  • My Preferred Research LLC /ID# 249720

    Miami, FL 33155

  • Coastal Georgia Child Neurology /ID# 249733

    Brunswick, GA 31520-1601

    Site contact: Site Coordinator · 770-376-7912

  • Deaconess Clinic - Gateway Health Center /ID# 247589

    Newburgh, IN 47630

    Site contact: Site Coordinator · 812-474-7184

  • Michigan Headache & Neurological Institute (MHNI) /ID# 247468

    Ann Arbor, MI 48104-5131

    Site contact: Site Coordinator · 734-677-6000

  • Proven Endpoints LLC /ID# 258066

    Ridgeland, MS 39157

    Site contact: Site Coordinator · 601-790-1811

  • Goryeb Childrens Hospital /ID# 249724

    Morristown, NJ 07960

  • Dent Neurologic Institute - Amherst /ID# 248534

    Amherst, NY 14226

    Site contact: Site Coordinator · 716-558-5670

  • Headache Wellness Center /ID# 251018

    Greensboro, NC 27405

  • Patient Priority Clinical Sites, LLC /ID# 247535

    Cincinnati, OH 45215-2123

    Site contact: Site Coordinator · 513-791-7760

  • Cincinnati Childrens Hospital Medical Center /ID# 258070

    Cincinnati, OH 45229

  • Children's Hospital of Philadelphia - Main /ID# 258071

    Philadelphia, PA 19104-4319

  • Access Clinical Trials, Inc. /ID# 248532

    Nashville, TN 37203

  • UT Health Austin at Dell Children's Neurology Clinic /ID# 264082

    Austin, TX 78723-3079

  • Earle Research /ID# 248501

    Friendswood, TX 77546

    Site contact: Site Coordinator · 281-218-8080

  • ClinPoint Trials /ID# 248540

    Waxahachie, TX 75165-1430

  • Pantheon Clinical Research /ID# 251601

    Bountiful, UT 84010-4968

  • Alpine Research Organization - Clinton /ID# 276497

    Clinton, UT 84015

  • Highland Clinical Research /ID# 247590

    Salt Lake City, UT 84124

  • Office of Maria Ona /ID# 249738

    Franklin, VA 23851

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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A Study to Assess the Adverse Events and Change in Disease… (NCT05711394) | Bored Studies